Medico-economic impact of thoracoscopy versus thoracotomy in lung cancer: multicentre randomised controlled trial (Lungsco01).

BACKGROUND: Lungsco01 is the first study assessing the real benefits and the medico-economic impact of video-thoracoscopy versus open thoracotomy for non-small cell lung cancer in the French context. METHODS: Two hundred and fifty nine adult patients from 10 French centres were randomised in this prospective multicentre randomised controlled trial, between July 29, 2016, and November 24, 2020. Survival from surgical intervention to day 30 and later was compared with the log-rank test. Total quality-adjusted-life-years (QALYs) were calculated using the EQ-5D-3L®. For medico-economic analyses at 30 days and at 3 months after surgery, resources consumed were valorised (€ 2018) from a hospital perspective. First, since mortality was infrequent and not different between the two arms, cost-minimisation analyses were performed considering only the cost differential. Second, based on complete cases on QALYs, cost-utility analyses were performed taking into account cost and QALY differential. Acceptability curves and the 95% confidence intervals for the incremental ratios were then obtained using the non-parametric bootstrap method (10,000 replications). Sensitivity analyses were performed using multiple imputations with the chained equation method. RESULTS: The average cumulative costs of thoracotomy were lower than those of video-thoracoscopy at 30 days (€9,730 (SD = 3,597) vs. €11,290 (SD = 4,729)) and at 3 months (€9,863 (SD = 3,508) vs. €11,912 (SD = 5,159)). In the cost-utility analyses, the incremental cost-utility ratio was €19,162 per additional QALY gained at 30 days (€36,733 at 3 months). The acceptability curve revealed a 64% probability of efficiency at 30 days for video-thoracoscopy, at a widely-accepted willingness-to-pay threshold of €25,000 (34% at 3 months). Ratios increased after multiple imputations, implying a higher cost for video-thoracoscopy for an additional QALY gain (ratios: €26,015 at 30 days, €42,779 at 3 months). CONCLUSIONS: Given our results, the economic efficiency of video-thoracoscopy at 30 days remains fragile at a willingness-to-pay threshold of €25,000/QALY. The economic efficiency is not established beyond that time horizon. The acceptability curves given will allow decision-makers to judge the probability of efficiency of this technology at other willingness-to-pay thresholds. TRIAL REGISTRATION: NCT02502318.

Robotic Lobectomy Is Cost-effective and Provides Comparable Health Utility Scores to Video-assisted Lobectomy: Early Results of the RAVAL Trial.

OBJECTIVE: The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy). BACKGROUND: Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery. METHODS: Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations. RESULTS: Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months. CONCLUSION: Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.

RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer.

BACKGROUND: Retrospective data demonstrates that robotic-assisted thoracoscopic surgery provides many benefits, such as decreased postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration, and reductions in the incidence of common postoperative pulmonary complications, when compared to video-assisted thoracoscopic surgery. Despite the potential benefits of robotic surgery, there are two major barriers against its widespread adoption in thoracic surgery: lack of high-quality prospective data, and the perceived higher cost of it. Therefore, in the face of these barriers, a prospective randomized controlled trial comparing robotic- to video-assisted thoracoscopic surgery is needed. The RAVAL trial is a two-phase, international, multi-centered, blinded, parallel, randomized controlled trial that is comparing robotic- to video-assisted lobectomy for early-stage non-small cell lung cancer that has been enrolling patients since 2016. METHODS: The RAVAL trial will be conducted in two phases: Phase A will enroll 186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy; while Phase B will continue to recruit until 592 patients are enrolled. After consent, participants will be randomized in a 1:1 ratio to either robotic- or video-assisted lobectomy, and blinded to the type of surgery they are allocated to. Health-related quality of life questionnaires will be administered at baseline, postoperative day 1, weeks 3, 7, 12, months 6, 12, 18, 24, and years 3, 4, 5. The primary objective of the RAVAL trial is to determine the difference in patient-reported health-related quality of life outcomes between the robotic- and video-assisted lobectomy groups at 12 weeks. Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms. The results of the primary objective will be reported once Phase A has completed accrual and the 12-month follow-ups are completed. The results of the secondary objectives will be reported once Phase B has completed accrual and the 5-year follow-ups are completed. DISCUSSION: If successfully completed, the RAVAL Trial will have studied patient-reported outcomes, cost-effectiveness, and survival of robotic- versus video-assisted lobectomy in a prospective, randomized, blinded fashion in an international setting. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02617186. Registered 22-September-2015. https://clinicaltrials.gov/ct2/show/NCT02617186.

Medico-economic impact of robot-assisted lung segmentectomy: what is the cost of the learning curve?

OBJECTIVES: The objective of this study was to assess the learning curve (LC) of robot-assisted lung segmentectomy and to evaluate hospital-related costs. METHODS: We conducted a retrospective study of Robot-assisted thoracic surgery (RATS) segmentectomies performed by 1 surgeon during 5 years. Perioperative and medical device data were collected. The LC, based on operating time, was assessed by Cumulative SUM analysis and an exponential model. Cost of care was estimated using the French National Cost Study method. RESULTS: One hundred and two RATS segmentectomies were included. The LC was completed at ∼30 procedures according to both models without significant difference in patients' characteristics before or after the LC. Mean operative time decreased from 136 min [95% confidence intervals (CI) 124-149] for the first 30 procedures to 97 min (95% CI 88-107) for the last 30 procedures. Mean length of stay decreased non-significantly (P = 0.10 for linear trend) from 8.1 days (95% CI 6.1-11.0) to 6.2 days (95% CI 4.9-7.9). The overall costs for the last 30 procedures as compared with the first 30 did not significantly decrease in the primary economic analysis but significantly decreased (P = 0.02) by €1271 (95% CI -2688 to +108, P = 0.02 for linear trend) after exclusion of 1 outlier (hospitalization-related costs > €10 000). After exclusion of this outlier, costs related to EndoWrist® instruments significantly decreased by €-135 (95% CI -220 to -35, P = 0.004), whereas costs related to clips decreased non-significantly (P = 0.28). CONCLUSIONS: The LC was completed at ∼30 procedures. Inexperienced surgeons may have higher procedure costs, related to consumable medical devices and operating time.

Comparison of Epithor clinical national database and medico-administrative database to identify the influence of case-mix on the estimation of hospital outliers.

BACKGROUND: The national Epithor database was initiated in 2003 in France. Fifteen years on, a quality assessment of the recorded data seemed necessary. This study examines the completeness of the data recorded in Epithor through a comparison with the French PMSI database, which is the national medico-administrative reference database. The aim of this study was to demonstrate the influence of data quality with respect to identifying 30-day mortality hospital outliers. METHODS: We used each hospital's individual FINESS code to compare the number of pulmonary resections and deaths recorded in Epithor to the figures found in the PMSI. Centers were classified into either the good-quality data (GQD) group or the low-quality data (LQD) group. To demonstrate the influence of case-mix quality on the ranking of centers with low-quality data, we used 2 methods to estimate the standardized mortality rate (SMR). For the first (SMR1), the expected number of deaths per hospital was estimated with risk-adjustment models fitted with low-quality data. For the second (SMR2), the expected number of deaths per hospital was estimated with a linear predictor for the LQD group using the coefficients of a logistic regression model developed from the GQD group. RESULTS: Of the hospitals that use Epithor, 25 were classified in the GQD group and 75 in the LQD group. The 30-day mortality rate was 2.8% (n = 300) in the GQD group vs. 1.9% (n = 181) in the LQD group (P <0.0001). The between-hospital differences in SMR1 appeared substantial (interquartile range (IQR) 0-1.036), and they were even higher in SMR2 (IQR 0-1.19). SMR1 identified 7 hospitals as high-mortality outliers. SMR2 identified 4 hospitals as high-mortality outliers. Some hospitals went from non-outlier to high mortality and vice-versa. Kappa values were roughly 0.46 and indicated moderate agreement. CONCLUSION: We found that most hospitals provided Epithor with high-quality data, but other hospitals needed to improve the quality of the information provided. Quality control is essential for this type of database and necessary for the unbiased adjustment of regression models.

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

INTRODUCTION: In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact. METHODS AND ANALYSIS: The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients. ETHICS AND DISSEMINATION: The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02502318.

The affordability of minimally invasive procedures in major lung resection: a prospective study.

OBJECTIVES: Minimally invasive procedures are used for the surgical treatment of lung cancer. Two techniques are proposed: video-assisted thoracic surgery or robotic-assisted thoracic surgery. Our goal was to study the economic impact of our long-standing program for minimally invasive procedures for major lung resection. METHODS: We conducted a single-centre, 1-year prospective cost study. Patients who underwent lobectomy or segmentectomy were included. Patient characteristics and perioperative outcomes were collected. Medical supply expenses based on the microcosting method and capital depreciation were estimated. Total cost was evaluated using a national French database. RESULTS: One hundred twelve patients were included, 57 with and 55 without robotic assistance. More segmentectomies were performed with robotic assistance. The median length of stay was 5 days for robotic-assisted and 6 days for video-assisted procedures (P = 0.13). The duration of median chest drains (4 days, P = 0.36) and of operating room time (255 min, P = 0.55) was not significantly different between the groups. The overall conversion rate to thoracotomy was 9%, significantly higher in the video-assisted group than in the robotic group (16% vs 2%, P = 0.008). No difference was observed in postoperative complications. The cost of most robotic-assisted procedures ranged from €10 000 to €12 000 (median €10 972) and that of most video-assisted procedures ranged from €8 000 to €10 000 (median €9 637) (P = 0.007); median medical supply expenses were €3 236 and €2 818, respectively (P = 0.004). The overall mean cost of minimally invasive techniques (€11 759) was significantly lower than the mean French cost of lung resection surgical procedures (€13 424) (P = 0.001). CONCLUSIONS: The cost at our centre of performing minimally invasive surgical procedures appeared lower than the cost nationwide. Robotic-assisted thoracic surgery demonstrated acceptable additional costs for a long-standing program.

The Interest of Performing "On-Demand Chest X-rays" after Lung Resection by Minimally Invasive Surgery.

Background There is a lack of consensus in hospital centers regarding costly daily routine chest X-rays after lung resection by minimally invasive surgery. Indeed, there is no evidence that performing daily chest X-rays prevents postoperative complications. Our objective was to compare chest X-rays performed on demand when there was clinical suspicion of postoperative complications and chest X-rays performed systematically in daily routine practice. Methods This prospective single-center study compared 55 patients who had on-demand chest X-rays and patients in the literature who had daily routine chest X-rays. Our primary evaluation criterion was length of hospitalization. Results The length of hospitalization was 5.3 ± 3.3 days for patients who had on-demand X-rays, compared with 4 to 9.7 days for patients who had daily routine X-rays. Time to chest tube removal (4.34 days), overall complication rate (27.2%), reoperation rate (3.6%), and mortality rate (1.8%) were comparable to those in the literature. On average, our patients only had 1.22 ± 1.8 on-demand X-rays, compared with 3.3 X-rays if daily routine protocol had been applied. Patients with complications had more X-rays (3.4 ± 1.8) than patients without complications (0.4 ± 0.7). Conclusion On-demand chest X-rays do not seem to delay the diagnosis of postoperative complications or increase morbidity-mortality rates. Performing on-demand chest X-rays could not only simplify surgical practice but also have a positive impact on health care expenses. However, a broader randomized study is warranted to validate this work and ultimately lead to national consensus.

Physiologic assessment before video thoracoscopic resection for lung cancer in patients with abnormal pulmonary function.

BACKGROUND: Impaired respiratory function may prevent curative surgery for patients with non-small cell lung cancer (NSCLC). Video-assisted thoracoscopic surgery (VATS) reduces postoperative morbility-mortality and could change preoperative assessment practices and therapeutic decisions. We evaluated the relation between preoperative pulmonary function tests and the occurrence of postoperative complications after VATS pulmonary resection in patients with abnormal pulmonary function. METHODS: We included 106 consecutive patients with ≤80% predicted value of presurgical expiratory volume in one second (FEV1) and/or diffusing capacity of carbon monoxide (DLCO) and who underwent VATS pulmonary resection for NSCLC from a prospective surgical database. RESULTS: Patients (64±9.5 years) had lobectomy (n=91), segmentectomy (n=7), bilobectomy (n=4), or pneumonectomy (n=4). FEV1 and DLCO preoperative averages were 68%±21% and 60%±18%. Operative mortality was 1.89%. Only FEV1 was predictive of postoperative complications [odds ratio (OR), 0.96; 95% confidence interval (CI), 0.926-0.991, P=0.016], but there was no determinable threshold. Twenty-five patients underwent incremental exercise testing. Desaturations during exercise (OR, 0.462; 95% CI, 0.191-0.878, P=0.039) and heart rate (HR) response (OR, 0.953; 95% CI, 0.895-0.993, P=0.05) were associated with postoperative complications. CONCLUSIONS: FEV1 but not DLCO was a significant predictor of pulmonary complications after VATS pulmonary resection despite a low rate of severe morbidity. Incremental exercise testing seems more discriminating. Further investigation is required in a larger patient population to change current pre-operative threshold in a new era of minimally invasive surgery.